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Randomized clinical trial comparing endovenous

laser ablation, radiofrequency ablation, foam


sclerotherapy, and surgical stripping for great
saphenous varicose veins with 3-year follow-up
Lars Rasmussen, DMSC, Martin Lawaetz, MS, Julie Serup, MS, Lars Bjoern, MD, Bo Vennits, MD,
Allan Blemings, MSc, and Bo Eklof, MD, Naestved, Denmark

Introduction: This study compares the outcome 3 years after treated GSV; CLF, EVLA, UGFS, and stripping, respec-
treatment of varicose veins by endovenous laser ablation tively; P < .01). Seventeen (KM estimate, 14.9%), 24 (KM
(EVLA), radiofrequency ablation, ultrasound-guided foam estimate, 20%), 20 (KM estimate, 19.1%), and 22 (KM
sclerotherapy (UGFS), or surgery by assessing recurrence, estimate, 20.2%) legs developed recurrent varicose veins
Venous Clinical Severity Score (VCSS), and quality of life (P [ NS). The patterns of reux and location of recurrent
(QOL). varicose veins were not different between the groups. Within
Methods: A total of 500 patients (580 legs) were randomized to 3 years after treatment, 12 (KM estimate, 11.1%), 14
one of the three endovenous treatments or high ligation and (KM estimate, 12.5%), 37 (KM estimate, 31.6%), and 18
stripping of the great saphenous vein (GSV). Follow-up (KM estimate, 15.5%) legs were retreated in the CLF,
included clinical and duplex ultrasound examinations and EVLA, UGFS, and stripping groups, respectively (P < .01).
VCSS and QOL questionnaires. Kaplan-Meier (KM) life-table VCSS, SF-36, and Aberdeen QOL scores improved signi-
analysis was used. P values below .05 were considered statis- cantly in all the groups with no difference between the
tically signicant. groups.
Results: At 3 years, eight (KM estimate, 7%), eight (KM Conclusions: All treatment modalities were efcacious and
estimate, 6.8%), 31 (KM estimate, 26.4%), and eight (KM resulted in a similar improvement in VCSS and QOL. How-
estimate, 6.5%) of GSVs recanalized or had a failed stripping ever, more recanalization and reoperations were seen after
procedure (more than 10 cm open reuxing part of the UGFS. (J Vasc Surg: Venous and Lym Dis 2013;1:349-56.)

Varicose veins are common and affect approximately Indeed, in the American guidelines for treatment of venous
25% of Western adults.1 The condition is most often associ- disease, thermoablation is preferred instead of surgical
ated with great saphenous vein (GSV) reux. Until recently, stripping.8 According to the guidelines, such preference is
the gold standard treatment of such condition has been high based on the patients recovery, which, in some studies,
ligation combined with stripping and phlebectomies. Such appears to be easier following endovenous treatment. In
treatment efciently improves symptoms and quality of life addition, several studies have described a high degree of
(QOL).2,3 However, the rate of recurrence, which may be efcacy regarding endovenous ablation of the GSV in the
caused by neovascularization, progression of disease, or short and medium term.9 However, little is known
technical or tactical errors, is high.4-7 regarding the difference in clinical recurrence between
In the recent decade, minimally invasive treatments, the endovenous methods and surgery.10 The present
based on radiofrequency ablation (RFA) or endovenous randomized trial, which compares RFA, EVLA, UGFS,
laser ablation (EVLA) of the saphenous veins (thermoabla- and stripping, was initiated in 2007. The short-term results
tion) has more or less replaced surgical stripping in (1-year) were published in 2011.11 The present publication
the U.S., whereas in Europe, stripping is still the most report the medium-term (3-year) outcome and describes
used treatment. In addition, ultrasound-guided foam the clinical and ultrasound recurrence, number of reopera-
sclerotherapy (UGFS) has become increasingly popular. tions, Venous Clinical Severity Score (VCSS), and QOL.
The regional ethics committee approved the study. All
From the Danish Vein Centers and Surgical Center Roskilde.
patients gave informed consent.
Author conict of interest: none.
Reprint requests: Dr Lars Rasmussen, The Danish Vein Centers, Eskadrons-
METHODS
vej 4A, 4700 Naestved, Denmark (e-mail: lhr@varix.dk).
The editors and reviewers of this article have no relevant nancial relation- The study was conducted in two private surgical
ships to disclose per the Journal policy that requires reviewers to decline centers, which work under contract to the national
review of any manuscript for which they may have a conict of interest.
2213-333X/$36.00
health care insurance in Denmark. The primary endpoint
Copyright 2013 by the Society for Vascular Surgery. was closed or absent GSV. An open reuxing segment of
http://dx.doi.org/10.1016/j.jvsv.2013.04.008 the treated part of the GSV of 10 cm or more was

349
JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
350 Rasmussen et al October 2013

RFA A

RFA

Fig 1. CONSORT ow chart. EVLA, Endovenous laser ablation; RFA, radiofrequency ablation; UGFS, ultrasound-
guided foam sclerotherapy.

considered a failure to strip the vein (technical failure) or a solution of 0.1% lidocaine with adrenaline and bicar-
recanalization. Secondary endpoints were the presence of bonate. A light sedation with midazolam and alfentanil or
varicose veins during follow-up, frequency of reoperations, diazepam was administered intravenously in most cases.
VCSS, and QOL. The details of the methodology have The surgical procedure was carried out through a 4- to
been previously described.11 In brief, consecutive patients 6-cm incision in the groin, with ush division and ligation
with symptomatic varicose veins and GSV incompetence, of the GSV and division and ligation of all tributaries. The
CEAP C2-4EpAsPr, were randomized to the trial using GSV was then removed to just below the knee using a pin
sealed envelopes. Exclusion criteria were duplication of stripper.
the saphenous trunk or an incompetent accessory GSV The CLF procedure was performed according to the
(AAGSV), small saphenous or deep venous incompetence, manufacturers recommendations.12 The GSV was cannulated
previous deep vein thrombosis, arterial insufciency, or
a tortuous GSV rendering the vein unsuitable for endove-
nous treatment. All treatments and assessments were per- Table I. Baseline characteristics in patients treated for
formed by one of three vascular and general surgeons varicose veins and GSV incompetence
with experience in the management of venous disease.
Bilateral treatment was permitted, provided both limbs RFA EVLA UGFS Stripping
received the same treatment during the same operation. No. of patients 125 125 125 124
Patients who had undergone previous high ligation or No. of legs 148 144 144 142
phlebectomies were included in the trial. The patients Bilaterala 23 19 19 18
were treated with one of the following methods: RFA Age, yearsb 51 (23-77) 52 (18-74) 51 (18-75) 50 (19-72)
c
Female 70 72 76 77
(ClosureFast [CLF]; Covidien, Manseld, Mass), EVLA
CEAP C2-C3a 92 95 96 97
(ELVES, Ceralas D 980 or D 1470, bare ber; Biolitec, CEAP C4-C6a 8 5 4 3
Bonn, Germany), UGFS with Aethoxysclerol 3%, 2-mL
solution mixed with 8-mL air according to the method EVLA, Endovenous laser ablation; GSV, great saphenous vein; RFA, radio-
frequency ablation; UGFS, ultrasound-guided foam sclerotherapy.
of Tessari (Polidocanol; Kreussler, Wiesbaden, Germany), a
% of legs.
or PIN stripping. All treatments were performed in a treat- b
Mean (range).
ment room under tumescent local anesthesia using c
% of patients.
JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
Volume 1, Number 4 Rasmussen et al 351

Fig 2. Kaplan-Meier (KM) plot of open reuxing great saphenous veins (GSVs). The KM gures represent time to the
event. CIs, Condence intervals; EVLA, endovenous laser ablation; RFA, radiofrequency ablation; UGFS, ultrasound-
guided foam sclerotherapy.

just below the knee, or at the lowest point of reux on the the vein. When this was achieved, further injection was
thigh. The ber or catheter was advanced to 1 to 2 cm below stopped. Varicose veins were removed by miniphlebectomies
the saphenofemoral junction and withdrawn during ablation. during the same procedure in all the treatment groups.
The EVLA procedure was performed under duplex guidance Assessments. The patients were examined at the time
with a 980-nm diode laser for the rst 17 legs, and a 1470- of randomization, and after 3 days, 1 month, and 1 and 3
nm for the rest using 12-watt power. Foam was injected years. The present report describes the ndings at 1 to 3
through one or two intravenous cannulas in the GSV at knee years. It is intended to continue the follow-up again at
level and in the thigh. Before injection of the foam, the patient 5 years after the treatment. At the initial visit, the surgeon
was placed in Trendelenburg position. The progression of obtained the medical history, performed a clinical and
foam in the GSV was followed with ultrasound to ensure duplex examination, and determined the CEAP class and
a complete lling to the junction and subsequent spasm of VCSS.13,14 The duration of reux and the diameter of the

Fig 3. Kaplan-Meier (KM) plot of recurrent varicose veins. The KM gures represent time to the event. CIs,
Condence intervals; EVLA, endovenous laser ablation; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam
sclerotherapy.
JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
352 Rasmussen et al October 2013

Table II. Topographical sites of REVAS: Number of recurrences and pattern of reux

RFA EVLA UGFS Stripping P

Total legs 148 144 145 143


Clinical recurrence 17 (11) 24 (17) 20 (14) 22 (15) .66
Reux in the groin 0 (0) 1 (4) 4 (20) 0 (0) .034
Reux in thigh 10 (59) 17 (71) 9 (45) 14 (64) .28
Reux in popliteal fossa 0 (0) 1 (4) 1 (5) 0 (0) .57
Reux in lower leg, ankle, and foot 12 (71) 18 (75) 5 (25) 13 (59) .047
Other 0 (0) 0 (0) 1 (5) 0 (0) .39

EVLA, Endovenous laser ablation; REVAS, REcurrence after VAricose vein Surgery; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam
sclerotherapy.
Numbers shown as number of legs (% of recurrences).

GSV 3 cm below the saphenofemoral junction were (ie, testing the hypothesis that there are equal treatment
measured. The Aberdeen Varicose Vein Symptom Severity effects across all groups). QOL endpoints, AVVSS, SF-36,
Score (AVVSS) and the Medical Outcomes Study Short and VCSS were analyzed using analysis of covariance. The
Form 36 (SF-36; Quality Metric, Lincoln, RI) health- analysis was performed in SAS version 9.1 (SAS Institute,
related QOL score were completed by the patients and Cary, NC).
recorded by the research nurse. The AVVSS is a validated
instrument for measurement of disease-specic QOL in RESULTS
patients with varicose veins. It produces a score from 0 (no A total of 500 consecutive patients (580 legs) were
venous symptoms) to 100 (worst venous symptoms).15 randomized to receive treatment. The number of patients
The SF-36 is a generic QOL instrument, which consists and legs treated and examined at follow-up is shown in the
of eight domains: physical functioning, role e physical, CONSORT diagram (Fig 1). Baseline patient characteristics
bodily pain, general health, vitality, social functioning, are shown in Table I. The groups were comparable with
role e emotional, and mental health. Each domain is regard to patient characteristics and CEAP classication of
scored from 0 (worst) to 100 (best).16 the treated legs. Nine, nine, 10, and 16 patients had under-
Statistical analysis. All analyses were assessed for the gone previous high ligation and/or phlebectomies in the
full analysis set, comprising all patients undergoing treat- CLF, EVLA, foam, and stripping group, respectively.
ment. The primary endpoint, closed or absent GSV, and Detailed information regarding treatment characteristics
secondary endpoints, recurrent varicose veins and freq- has been published before.11
uency of reoperations, were analyzed by Kaplan-Meier GSV data. The KM plot of the open, reuxing
(KM) survival methods as time to rst endpoints. The GSVs are shown in Fig 2. The KM gures represent
P value represents a comparison across all treatment groups time to the event, and the probability on the plots is

Fig 4. Kaplan-Meier (KM) plot of reoperations. The KM gures represent time to the event. CIs, Condence intervals;
EVLA, endovenous laser ablation; RFA, radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy.
JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
Volume 1, Number 4 Rasmussen et al 353

Fig 5. Venous Clinical Severity Score (VCSS). CIs, Condence intervals; EVLA, endovenous laser ablation; RFA,
radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy.

freedom from the event. The KM estimates are 1-KM (KM estimate, 14.9%), 24 (KM estimate, 20%), 20 (KM
and represent the percentage of patients who had estimate, 19.1%), and 22 (KM estimate 20.2%) legs during
failure, recurrent varicose veins, or reoperation. Eight the 3 years in the CLF, EVLA, UGFS, and stripping group,
(KM estimate, 7%), eight (KM estimate, 6.8%), 31 (KM respectively (P .6596). Table II shows the distribution of
estimate, 26.4%), and eight (KM estimate, 6.5%) of the recurrent varicose veins. More patients in the UGFS
GSVs were recorded as having open and reuxing group had reux in the groin compared with the other
segments of 10 cm or more during the rst 3 years in groups (P .034).
the CLF, EVLA, UGFS, and stripping group, respec- Reoperations. The KM plot of legs with reoperations
tively (P < .0001). is shown in Fig 4. Twelve (KM estimate, 11.1%), 14 (KM
Clinical recurrence and pattern of reux. The KM estimate, 12.5%), 37 (KM estimate, 31.6%), and 18 (KM
plot of legs with recurrent varicose veins is shown in estimate, 15.5%) legs were retreated in the CLF, EVLA,
Fig 3. Recurrent varicose veins were recorded in 17 UGFS, and stripping group, respectively, during the 3-year

Fig 6. Aberdeen Varicose Vein Severity Score (AVVSS). CIs, Condence intervals; EVLA, endovenous laser ablation;
RFA, radiofrequency ablation; UGFS, ultrasound-guided foam sclerotherapy.
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354 Rasmussen et al October 2013

Table III. SF-36 health-related QOL outcomes after treatment of varicose veins

SF-36 Pretreatment 1-year 2-year 3-year Pa to 3 years

PF
RFA 84.05 (18.50) 92.22 (12.62) 89.57 (19.83) 88.03 (17.12) .0101
EVLA 83.16 (16.85) 92.02 (11.61) 88.32 (18.77) 91.46 (13.82) <.0001
UGFS 83.49 (17.72) 91.33 (14.93) 90.5 (15.7) 88.98 (18.21) .0224
Stripping 83.31 (18.89) 92.82 (13.35) 92.69 (12.06) 90.56 (15.23) .0008
RP
RFA 87.15 (21.44) 94.65 (10.64) 92.84 (16.79) 88.08 (21.47) .7115
EVLA 83.80 (22.31) 93.51 (14.78) 90.21 (19.64) 90.08 (19.37) .0054
UGFS 86.49 (21.48) 90.36 (20.56) 91.01 (17.73) 89.7 (20.10) .0898
Stripping 85.35 (20.38) 93.41 (16.32) 93.75 (16.67) 90.84 (19.80) .3390
BP
RFA 72.71 (22.37) 89.92 (16.85) 87.78 (19.36) 85.35 (19.93) <.0001
EVLA 70.94 (20.96) 88.43 (19.55) 83.34 (21.21) 81.22 (26.00) .0013
UGFS 71.40 (20.37) 85.11 (23.45) 83.83 (21.50) 85.74 (20.61) <.0001
Stripping 71.30 (22.05) 88.77 (17.11) 89.65 (17.73) 87.86 (19.49) .0001
GH
RFA 62.38 (13.30) 67.08 (11.82) 65.33 (12.38) 62.53 (15.31) .6055
EVLA 60.55 (13.76) 64.90 (11.99) 63.38 (14.14) 61.11 (15.24) .5638
UGFS 62.58 (15.00) 63.36 (18.31) 62.79 (15.98) 65.55 (14.77) .2054
Stripping 63.57 (15.01) 66.02 (14.00) 66.58 (12.53) 65.14 (15.71) .4618
VT
RFA 66.99 (19.30) 76.00 (17.51) 79.34 (15.86) 75.56 (19.26) <.0008
EVLA 64.68 (18.60) 77.74 (14.03) 72.59 (16.65) 74.60 (17.74) <.0001
UGFS 68.07 (20.47) 73.20 (22.67) 73.46 (17.76) 74.17 (20.77) .0910
Stripping 66.90 (21.53) 76.99 (15.54) 77.22 (14.88) 75.32 (18.38) .0070
SF
RFA 93.15 (14.38) 97.11 (84.45) 97.56 (11.19) 93.95 (16.21) .8255
EVLA 92.93 (15.74) 96.51 (11.22) 94.13 (18.03) 92.86 (16.30) .8525
UGFS 92.07 (18.41) 93.10 (16.51) 95.47 (12.49) 95.75 (12.72) .3647
Stripping 90.36 (17.56) 95.19 (11.60) 96.52 (10.39) 96.77 (8.93) .0068
RE
RFA 91.67 (16.02) 94.50 (11.02) 95.58 (12.53) 92.95 (17.63) .8807
EVLA 88.67 (20.40) 95.95 (10.15) 91.77 (18.93) 89.42 (21.85) .5551
UGFS 92.41 (16.73) 91.92 (17.11) 92.02 (14.36) 91.20 (18.42) .5562
Stripping 88.17 (18.68) 94.20 (14.02) 95.52 (12.71) 94.83 (14.29) .0243
MH
RFA 80.18 (14.70) 87.08 (11.94) 86.89 (13.58) 86.62 (13.89) .0039
EVLA 80.34 (15.05) 87.70 (10.51) 85.90 (13.48) 83.97 (15.87) .0914
UGFS 83.00 (16.05) 84.58 (15.77) 83.91 (14.03) 84.34 (16.38) .8055
Stripping 79.27 (16.04) 85.92 (12.18) 87.28 (11.37) 84.83 (13.21) .1305
MCS
RFA 53.97 (8.51) 56.52 (6.17) 57.26 (6.82) 56.34 (7.30) <.0001
EVLA 53.72 (8.99) 56.74 (5.44) 55.92 (6.84) 53.90 (10.13) <.0001
UGFS 55.14 (8.87) 54.91 (8.21) 54.82 (6.74) 55.32 (9.19) <.0001
Stripping 53.03 (9.03) 55.69 (6.39) 56.50 (5.47) 55.89 (6.27) <.0001
PCS
RFA 49.11 (8.43) 53.24 (5.32) 52.09 (7.27) 50.66 (7.77) <.0001
EVLA 48.27 (7.41) 52.62 (5.98) 51.12 (7.66) 52.33 (6.32) <.0001
UGFS 48.25 (8.03) 52.14 (7.38) 51.76 (7.93) 51.89 (8.08) <.0001
Stripping 49.20 (7.89) 53.51 (5.91) 53.11 (5.65) 52.27 (7.34) <.0001

BP, Bodily pain; EVLA, endovenous laser ablation; GH, general health; MCS, mental component summary; MH, mental health; PCS, physical component
summary; PF, physical functioning; QOL, quality of life; RFA, radiofrequency ablation; RE, roleeemotional; RP, roleephysical; SF, social functioning; UGFS,
ultrasound-guided foam sclerotherapy; VT, vitality.
Values are in mean (standard deviation).
a
P values are adjusted for baseline levels of the respective SF-36 scores.

follow-up (P < .0001). Most patients were treated with deviation) VCSS at the start of the study was 2.95 (2.06),
UGFS, in some cases combined with phlebectomies, which 2.68 (2.25), 2.66 (1.45), and 2.75 (1.62) and was reduced
is standard practice in our clinics. to 0.44 (1.82), 0.34 (1.3), 0.15 (0.4), and 0.3 (0.5) at 3
VCSS. The VCSS score improved signicantly in all years in the CLF, EVLA, UGFS, and stripping group,
groups (P < .0001), with no signicant difference between respectively.
the groups at any point in time (Fig 5). The improve- AVVSS. The AVVSS improved signicantly in all
ment lasted throughout the 3 years. The mean (standard groups from 3 days and onward (P < .0001), with no
JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
Volume 1, Number 4 Rasmussen et al 355

difference between the groups at any point in time (Fig 6). recanalized in this group. It is standard practice in our
The mean (standard deviation) AVVSS at the start of the clinics to offer retreatment in patients with a recanalized
study was 18.74 (8.63), 17.97 (9.00), 18.38 (9.07), and GSV following a primary treatment. Thus, the retreatment
19.3 (8.46) and was reduced to 4.43 (6.58), 4.61 (5.8), with foam was not necessarily performed because of symp-
4.76 (5.71), and 4.00 (4.87) at 3 years in the CLF, EVLA, toms or recurrent varicose veins. All four treatments signif-
UGFS, and stripping group, respectively. icantly improved VCSS and QOL as reected by signicant
SF-36 scores. Statistically signicant improvements improvements in AVVSS and in several domains of SF-36,
compared with baseline were seen in the domains of phys- with no signicant differences in the outcome between
ical functioning, role e physical, bodily pain, vitality, social the groups. The improvements persisted throughout the
functioning, role e emotional, and mental health at some 3 years and show that CLF, EVLA, UGFS, and stripping
point in time in some of the groups, and in the mental are efcient treatments with longer-term benecial effects
component summary, and physical component summary in patients with GSV varicose veins. This is true even
at all time points in all groups. (Table III) though more patients in the UGFS group developed recan-
alization of the GSV. One explanation may be the fact that
DISCUSSION all treatments were combined with miniphlebectomies.
Due to recanalization, signicantly more patients in the Thus, recanalization or failure to strip the GSV does not
UGFS group developed open reuxing GSV segments of appear to inuence the VCSS and QOL in this study.
more than 10 cm compared with patients treated with A shortcoming of the study is that it was not blinded.
the other modalities. The majority of recanalizations Whereas a study comparing different thermoablation
appeared within the rst year of follow-up. Our recanaliza- modalities may be blinded, it is not possible to blind the
tion rate is probably somewhat higher than previously treatment for the patient in a study such as ours. Blinding
described by authors using sodium tetradecyl sulfate in of the observer may be possible, but it is difcult. It should
a similar volume, but it seems to be as good, or even better, be noted however, that QOL data are based on the
than previously described after catheter-directed foam scle- patients own completions of questionnaires. Furthermore,
rotherapy with Polidocanol.17-19 Our protocol did not during follow-up visits, the observer would have no access
allow retreatment beyond the rst month, and only ve to information of the primary procedure and little recollec-
patients (ve legs) received such retreatment.11 Further tion of it.
sessions of UGFS would undoubtedly have improved the In conclusion, our study demonstrates that CLF,
closure rate. The failure to strip the GSV occurred in eight EVLA, UGFS, and stripping are efcient modalities for
legs because the vein snapped during the procedure and the treatment of GSV varicose veins in the medium term.
could not be retrieved. Accordingly, this failure represents Apart from a higher rate of recanalization after UGFS, it
a technical error, which is well known. No difference in appears that there is no difference regarding clinical recur-
GSV recanalization or failure to strip the vein (failure rence, VCSS, and QOL.
rate) was found between thermoablation and stripping.
Our nding is in line with previous studies comparing AUTHOR CONTRIBUTIONS
EVLA with stripping, showing no difference in efcacy of
Conception and design: LR, LB, BE
the two treatments.20-22 Our study is the rst to compare
Analysis and interpretation: LR, ML, JS, AB
CLF with the other modalities medium term in a random-
Data collection: LR, JS, LB, BV
ized trial. It shows that the efcacy of GSV ablation with
Writing the article: LR, ML, AB
CLF is not different from EVLA and stripping but consid-
Critical revision of the article: LR, ML, JS, AB, BE, BV
erably better than UGFS. The longer-term clinical impact
Final approval of the article: LR, ML, LB, JS, AB, BE, BV
of recanalized segments of the GSV is not known, however.
Statistical analysis: LR, ML, AB
In the present study with 3-year follow-up, GSV recanaliza-
Obtained funding: LR
tion or failure to strip was not associated with clinical recur-
Overall responsibility: LR
rence nor did it seem to inuence VCSS or QOL.
The clinical recurrence rate, as dened by the presence
of varicose veins after treatment (REVAS), was high in all REFERENCES
the groups, with no difference between the groups.4 1. Callam MJ. Epidemiology of varicose veins. Br J Surg 1994;81:167-73.
Such recurrence is well known from other studies where 2. Durkin MT, Turton EP, Wijesinghe LD, Scott DJ, Berridge DC. Long
varicose veins are carefully sought for, and it may well reach saphenous vein stripping and quality of lifeda randomised trial. Eur J
Vasc Endovasc Surg 2001;21:545-9.
more than 60% of legs after 11 years.5-7 The REVAS clas-
3. MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV,
sication was not different between the groups, thus Bradbury AW. The effect of long saphenous vein stripping on quality of
a previous nding of increased neovascularization in the life. J Vasc Surg 2002;35:1197-203.
groin after stripping compared with EVLA could not be 4. Perrin MR, Guex JJ, Ruckley CV, dePalma RG, Royle JP, Eklof B,
conrmed in the present study.23 However, such changes et al. Recurrent varices after surgery (REVAS), a consensus document.
REVAS group. Cardiovasc Surg 2000;8:233-45.
were only sought for in legs with REVAS. 5. Winterborn RJ, Foy C, Earnshaw JJ. Causes of varicose vein recur-
More patients in the UGFS group were retreated rence: late results of a randomized controlled trial of stripping the long
compared with the other groups because more GSVs saphenous vein. J Vasc Surg 2004;40:634-9.
JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISORDERS
356 Shortell October 2013

6. Kostas T, Ioannou CV, Touloupakis E, Daskalaki E, Giannoukas AD, Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg
Tsetis D, et al. Recurrent varicose veins after surgery: a new appraisal of 2010;52:1387-96.
a common and complex problem in vascular surgery. Eur J Vasc 15. Garratt AM, Macdonald LM, Ruta DA, Russell IT, Buckingham JK,
Endovasc Surg 2004;27:275-82. Krukowski ZH. Towards measurement of outcome for patients with
7. van Rij AM, Jiang P, Solomon C, Christie RA, Hill GB. Recurrence varicose veins. Qual Health Care 1993;2:5-10.
after varicose vein surgery: a prospective long-term clinical study with 16. Smith JJ, Garratt AM, Guest M, Greenhalgh RM, Davies AH. Evalu-
duplex ultrasound scanning and air plethysmography. J Vasc Surg ating and improving health-related quality of life in patients with
2003;38:935-43. varicose veins. J Vasc Surg 1999;30:710-9.
8. Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, 17. Darvall KA, Bate GR, Adam DJ, Silverman SH, Bradbury AW. Duplex
Gloviczki ML, et al. The care of patients with varicose veins and ultrasound outcomes following ultrasound-guided foam sclerotherapy
associated chronic venous diseases: clinical practice guidelines of the of symptomatic recurrent great saphenous varicose veins. Eur J Vasc
Society for Vascular Surgery and the American Venous Forum. J Vasc Endovasc Surg 2011;42:107-14.
Surg 2011;53(5 Suppl):2S-48S. 18. Coleridge Smith P. Foam and liquid sclerotherapy for varicose veins.
9. van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Phlebology 2009;24(Suppl 1):62-72.
Endovenous therapies of lower extremity varicosities: a meta-analysis. 19. Asciutto G, Lindblad B. Catheter-directed foam sclerotherapy treat-
J Vasc Surg 2009;49:230-9. ment of saphenous vein incompetence. Vasa 2012;41:120-4.
10. Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, 20. Christenson JT, Gueddi S, Gemayel G, Bounameaux H. Prospective
Duggirala MK, Erwin PJ, et al. A systematic review and meta-analysis randomized trial comparing endovenous laser ablation and surgery for
of the treatments of varicose veins. J Vasc Surg 2011;53(5 Suppl): treatment of primary great saphenous varicose veins with a 2-year
49S-65S. follow-up. J Vasc Surg 2010;52:1234-41.
11. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. 21. Rasmussen LH, Bjoern L, Lawaetz M, Lawaetz B, Blemings A,
Randomized clinical trial comparing endovenous laser ablation, radio- Eklof B. Randomised clinical trial comparing endovenous laser ablation
frequency ablation, foam sclerotherapy and surgical stripping for great with stripping of the great saphenous vein: clinical outcome and
saphenous varicose veins. Br J Surg 2011;98:1079-87. recurrence after 2 years. Eur J Vasc Endovasc Surg 2010;39:630-5.
12. Proebstle TM, Vago B, Alm J, Gockeritz O, Lebard C, Pichot O. 22. Carradice D, Mekako AI, Mazari FA, Samuel N, Hateld J, Chetter IC.
Treatment of the incompetent great saphenous vein by endovenous Randomized clinical trial of endovenous laser ablation compared with
radiofrequency powered segmental thermal ablation: rst clinical conventional surgery for great saphenous varicose veins. Br J Surg
experience. J Vasc Surg 2008;47:151-6. 2011;98:501-10.
13. Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, 23. Theivacumar NS, Darwood R, Gough MJ. Neovascularisation and
Meissner MH, Moneta GL. Venous severity scoring: an adjunct to recurrence 2 years after varicose vein treatment for sapheno-femoral
venous outcome assessment. J Vasc Surg 2000;31:1307-12. and great saphenous vein reux: a comparison of surgery and endo-
14. Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, venous laser ablation. Eur J Vasc Endovasc Surg 2009;38:203-7.
Gillespie D, et al. Revision of the venous clinical severity score: venous
outcomes consensus statement: special communication of the American Submitted Mar 27, 2013; accepted Apr 29, 2013.

INVITED COMMENTARY

Cynthia K. Shortell, MD, Durham, NC

In 2011, the authors published the initial 1-year results of this modalities and with faster recovery than laser and surgery. In the
large randomized controlled trial comparing endovenous laser present study, we see that the initial ndings with regard to
ablation, radiofrequency ablation, ultrasound-guided foam sclero- anatomic and quality of life persist at 3 years; that is to say that
therapy, and surgical stripping in the treatment of symptomatic anatomic results and freedom from reintervention were superior
reux of the great saphenous vein. This study quickly became in the thermal ablation and surgical group compared with the scle-
the most important work comparing the four treatment modalities, rotherapy group, but quality-of-life measures were not different.
as it provided comprehensive and scientically rigorous data on all While the study may not demonstrate clear superiority of one
important aspects of therapeutic outcomes: anatomic, functional, modality over others, it brings the differences into sharp focus.
quality of life, and cost. At 1 year, thermal ablation and surgical We may now share with our patients the options and potential
stripping were superior to foam sclerotherapy with regard to advantages of each of the possible treatments available to them
anatomic outcomes but not to quality-of-life metrics, although and have condence that they will have reliable data on which to
sclerotherapy was associated with reduced cost compared with all base their decision.

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